BEST-Study
Progressive Resistance Training and Progressive Muscle Relaxation during Radiotherapy as Adjuvant Treatment against Cancer-related Fatigue (“Bewegung und Entspannung für Brustkrebspatientinnen unter Strahlentherapie”)
In cooperation with the Radio-Oncology of the University Clinic of Heidelberg and the Research Group Translational Immunology at the DKFZ.
Investigators
Principal Investigators: Prof. Dr. Karen Steindorf, Prof. Dr. Cornelia Ulrich, Dr. Robert Owen, Prof. Dr. Philipp Beckhove, Dr. Karin Potthoff, PD Dr. Holger Hof
Co-Principal Investigators: Dr. Martina Schmidt, Dr. Joachim Wiskemann
Abstract
Cancer-related fatigue (CRF) is a multidimensional syndrome which occurs in the majority of cancer patients during anticancer treatment and potentially persists for many years after cure. Because of its multidimensionality, CRF is influenced by physical, psychological and also social factors. Summarized by an article of the Cochrane Collaboration, exercise is a promising intervention for the treatment of CRF in breast cancer patients. However, little is known about the effects of exercise and its biological mechanisms in cancer patients during radio-therapy. Further, nearly all studies in this field examined the effect of exercise against treatment-as-usual, mostly in group settings. Therefore, it is currently unknown if the beneficial effects are related to the physical training itself or caused by group-related psychosocial effects. Thus, the BEST study was designed to evaluate the potential benefits of progressive resistance training beyond group-related psychosocial effects and to evaluate potential biologic mechanisms.
BEST was a randomized controlled clinical trial, aimed to evaluate the effect of a high intensity, supervised and group-based resistance training on CRF in breast cancer patients during adjuvant radiotherapy, compared with a Progressive Muscle Relaxation (PMR) program.
All participants were requested to fill out standardized questionnaires concerning fatigue, quality of life and depression. In addition, physical performance (endurance and strength capacity), activity history and cognitive capacity will be assessed. Furthermore, blood, urine and saliva samples were collected for multiple analyses of immunological and inflammatory parameters and other biomarkers. The interventions started in parallel with the radiotherapy and ended after 24 sessions (2x/week) at week 13. Randomization was performed stratified for age and baseline fatigue levels. Data collection was performed at baseline (which is before start of radiotherapy), at end of radiotherapy, end of 12-week intervention, 3 months after end of radiotherapy, and 6 and 12 months after end of intervention.
Recruitment
Recruitment has begun in February 2011 and was completed at the end of April 2013. During that time 160 patients were enrolled.
Contact
Prof. Dr. Karen Steindorf
phone: +49 6221 42 2351
e-mail: karen.steindorf@nct-heidelberg.de
Registration
Publications
Zimmer P, Schmidt ME, Prentzell MT, Berdel B, Wiskemann J, Kellner KH, Debus J, Ulrich C, Opitz CA, Steindorf K(2019): Resistance exercise as IDO inhibitor? The influence of resistance exercise on the kynurenine pathway in patients with breast cancer undergoing radiotherapy – A randomized controlled trial. Frontiers in Oncology, Epub, 9:962. doi: 10.3389/fonc.2019.00962.
Pal A, Zimmer P, Schmidt ME, Hummels M., Ulrich CM, Wiskemann J, Steindorf K (2019): Resistance exercise does not influence the transcriptome of NK cells in breast cancer patients undergoing adjuvant therapy. Frontiers in Physiology, [Epub ahead of print]
van Vulpen JK, Sweegers MG, Peeters PHM, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, Galvão DA, Chinapaw MJ, Steindorf K, Irwin ML, Stuiver MM, Hayes S, Griffith KA, Mesters I, Knoop H, Goedendorp MM, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz KH, Short CE, James EL, Plotnikoff RC, Schmidt ME, Ulrich CM, van Beurden M, Oldenburg HS, Sonke GS, van Harten WH, Schmitz KH, Winters-Stone KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten MJ, Nollet F, Wenzel J, Wiskemann J, Verdonck-de Leeuw IM, Brug J, May AM, Buffart LM (2019): Moderators of Exercise Effects on Cancer-related Fatigue: A Meta-analysis of Individual Patient Data. Med Sci Sports Exerc, [Epub ahead of print]
Schmidt ME, Scherer S, Wiskemann J, Steindorf K (2019): Return to work after breast cancer: the role of treatment-related side effects and potential impact on quality of life. European Journal of Cancer Care, [Epub ahead of print].
Buffart LM, Sweegers MG, May AM, Chinapaw MJ, van Vulpen J, Newton RU, Galvão DA, Aaronson NK, Stuiver MM, Jacobsen PB, Verdonck-de Leeuw IM, Steindorf K, Irwin ML, Hayes S, Griffith KA, Lucia A, Mesters I, van Weert E, Knoop H, Goedendorp MM, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz KH, Short CE, James EL, Plotnikoff RC, Arbane G, Schmidt ME, Potthoff K, van Beurden M, Oldenburg HS, Sonke GS, van Harten WH, Garrod R, Schmitz KH, Winters-Stone KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten MJ, Nollet F, Wenzel J, Wiskemann J, Brug J, Courneya KS (2018): Targeting exercise interventions to patients with cancer in need: Results from an individual patient data meta-analysis. Journal of the National Cancer Institute, 110,1190-1200. doi: 10.1093/jnci/djy161.
Sweegers MG, Altenburg TM, Brug J, May AM, van Vulpen JK, Aaronson NK, Arbane G, Bohus M, Courneya KS, Daley AJ, Galvao DA, Garrod R, Griffith KA, van Harten WH, Hayes S, Herrero F, Kersten MJ, Lucia A, McConnachie A, van Mechelen W, Mutrie N, Newton RU, Nollet F, Potthoff K, Schmidt ME, Schmitz KH, Schulz KH, Sonke GS, Steindorf K, Stuiver MM, Taaffe DR, Thorsen L, Twisk JW, Velthuis MJ, Wenzel J, Winters-Stone KM, Wiskemann J, Chin A Paw MJ, Buffart LM (2018): Moderators of the exercise effects on physical fitness in patients with cancer: a meta-analysis of individual patient data. British Journal of Sports Medicine, 53, 812. Epub, doi: 10.1136/bjsports-2018-099191.
Schmidt M, Wiskemann J, Steindorf K (2018): Quality of life, problems, and needs of disease-free breast cancer survivors 5 years after diagnosis. Quality of Life Research, 27, 2077-2086.
Schmidt ME, Wiskemann J, Schneeweiss A, Potthoff K, Ulrich CM, Steindorf K (2018): Determinants of physical, affective, and cognitive fatigue during breast cancer therapy and 12 months follow-up. International Journal of Cancer, 142, 1148-1157.
Wiskemann J, Schmidt ME, Klassen O, Debus J, Ulrich CM, Potthoff K, Steindorf K (2017): Effects of 12-week resistance training during radiotherapy in breast cancer patients. Scandinavian Journal of Medicine and Science in Sports, 11, 1500-1510
Klassen O, Schmidt ME, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J (2017). Muscle strength in breast cancer patients receiving different treatment regimes. J Cachexia Sarcopenia Muscle 8:305-316.
Buffart, LM, Kalter J, Sweegers MG, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, May AM, Galvão DA, Chinapaw MJ, Steindorf K, Irwin ML, Stuiver MM, Hayes S, Griffith KA, Lucia A, Mesters I, van Weert E, Knoop H, Goedendorp M, Mutrie N, Daley AJ, McConnachie A, Bohus M, Thorsen L, Schulz K-H, Short CE, James EL, Plotnikoff RC, Arbane G, Schmidt ME, Potthoff K, van Beurden M, Oldenburg HS, Sonke GS, van Harten W, Garrod R, Schmitz KH, Winters KM, Velthuis MJ, Taaffe DR, van Mechelen W, Kersten M-J, Nollet F, Wenzel J, Wiskemann J, Verdonck-de Leeuw IM, Brug J: Effects and moderators of exercise on quality of life and physical function in patients with cancer: an individual patient data metaanalysis of 34 RCTs. Cancer Treat Rev;52:91-104
Schmidt ME, Wiskemann J, Ulrich CM, Schneeweiss A, Steindorf K (2017). Self-reported physical activity behavior of breast cancer survivors during and after adjuvant therapy: 12 months follow-up of two randomized exercise intervention trials. Acta Oncol 56:618-627
Steindorf K, Wiskemann J, Ulrich CM, Schmidt ME (2017). Effects of exercise on sleep problems in breast cancer patients receiving radiotherapy: a randomized clinical trial. Breast Cancer Res Treat, 162, 489-499.
Schmidt ME, Wiskemann J, Schneeweiss A, Potthoff K, Ulrich CM, Steindorf K (2017). Courses and determinants of physical, affective, and cognitive fatigue during breast cancer therapy and 12 months follow-up. Int J Cancer.
Wiskemann J, Schmidt ME, Klassen O, Ulrich CM, Potthoff K, Steindorf K (2016). Effects of 12-week resistance training during radiotherapy on isokinetic and isometric muscle strength in breast cancer patients. Scand J Med Sci Sports [Epub Oct 5]
Klassen O, Schmidt ME, Ulrich CM, Potthoff K, Steindorf K, Wiskemann J. Muscle strength in breast cancer patients undergoing adjuvant therapy (accepted by J Cachexia Sarcopenia Muscle, Oct 2016)
Schmidt ME, Meyenköhn A, Habermann N, Wiskemann J, Oelmann J, Hof H, Wessels S, Klassen O, Debus J, Potthoff K, Steindorf K, Ulrich CM (2016): Resistance exercise and inflammation in breast cancer patients undergoing adjuvant radiotherapy: Mediation analysis from a randomized controlled intervention trial. International Journal of Radiation Oncology, Biology, Physics 94:329-37
Schmidt ME, Semik J, Habermann N, Wiskemann J, Ulrich CM, Steindorf K (2016): Cancer-related fatigue shows a stable association with diurnal cortisol dysregulation in breast cancer patients. Brain Behavior and Immunity 52:98-105 (Epub 0ct 2015)
Gollhofer S, Wiskemann J, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Hof H, Potthoff K, Steindorf K (2015): Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy. BMC Cancer. 27;15:186 [Epub Mar 2015]
Scharhag-R F, Kühl R, Klassen O, Schommer K, Schmidt ME, Wiskemann J, Steindorf K (2015): Exercise training intensity prescription in breast cancer survivors: validity of current practice and specific recommendations. J Cancer Surviv, 9:612-9. [Epub Feb 2015]
Klassen O, Schmidt ME, Scharhag-Rosenberger F, Sorkin M, Ulrich CM, Schneeweiss A, Potthoff K, Steindorf K, Wiskemann J (2014): Cardiorespiratory fitness in breast cancer patients undergoing adjuvant therapy. Acta Oncol. May 16:1-10.
Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, Beckhove P, Owen R, Debus J, Wiskemann J, Potthoff K (2014): Randomized Controlled Trial of Resistance Training in Breast Cancer Patients Receiving Adjuvant Radiotherapy: Results on Cancer-related Fatigue and Quality of Life. Ann Oncol. 25:2237-43 [Epub Aug 2014] * shared first authorship
Potthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K (2013): Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer, 13:162 doi:10.1186/1471-2407-13-162